To date, Transcranial Pulse Stimulation has been approved for the “Treatment of the Central Nervous System in Alzheimer’s dementia”. Since Alzheimer’s dementia is often accompanied by other forms of dementia, mixed forms are also treated. However, others, presumably or logically all neurodegenerative diseases, will also be treatable with TPS in the future. But for each individual indication (each clinical picture), a separate individual approval must be obtained. This usually takes many years, is bound to strict clinical and bureaucratic guidelines – and of course costs a lot of money.
One sees this at the research and development in the Pharma industry: Here on the average 13 years pass, until an active substance receives an approval of whatever kind and according to investigations the average costs of the development of a new innovative medicine lie with up to 2.6 billion US dollar!
These rules also apply in medical technology, from which the TPS comes in practical implementation. But after all, the NEUROLITH, that is, the shock wave system for the implementation of transcranial pulse stimulation, after more than 30 years of research and development CE-approved for the treatment of the central nervous system in Alzheimer’s dementia. All other possible treatment options, some of which have already been implemented in practice, are so-called “off-label use” applications.